Application 020726

Type: NDA
Sponsor: NOVARTIS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FEMARA	LETROZOLE	TABLET;ORAL	2.5MG	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0249	Femara	letrozole	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0249	Femara	letrozole	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0249	Femara	letrozole	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0249	Femara	letrozole	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0249	Femara	letrozole	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0249	Femara	letrozole	Novartis Pharmaceuticals Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80621	SUPPL	2024-12-18
80602	SUPPL	2024-12-17
53636	SUPPL	2018-04-09
53631	SUPPL	2018-04-06
49015	SUPPL	2017-07-19
49006	SUPPL	2017-07-17
25647	SUPPL	2014-01-17
13302	SUPPL	2014-01-16
25646	SUPPL	2012-01-03
35241	SUPPL	2011-12-23
13300	SUPPL	2010-07-01
25645	SUPPL	2010-06-29
13301	SUPPL	2010-05-06
3216	SUPPL	2010-05-06
25642	SUPPL	2010-03-08
3215	SUPPL	2010-03-08
13299	SUPPL	2010-03-03
13298	SUPPL	2010-03-03
25644	SUPPL	2009-07-17
35240	SUPPL	2009-07-09
25643	SUPPL	2008-08-13
35239	SUPPL	2007-04-20
3214	SUPPL	2007-04-20
25641	SUPPL	2006-06-27
3213	SUPPL	2006-01-06
35238	SUPPL	2006-01-05
25640	SUPPL	2005-01-26
13297	SUPPL	2004-10-29
3212	SUPPL	2004-06-04
41623	ORIG	2003-08-07
25638	SUPPL	2003-03-10
13294	SUPPL	2003-03-04
13296	SUPPL	2003-01-17
25639	SUPPL	2001-01-10
20883	SUPPL	2001-01-10
13295	SUPPL	2001-01-10